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The mainstay of von Willebrand disease treatment is the replacement of the deficient protein (VWF)1
Quality: high molecular weight von Willebrand factor (HMW-VWF) multimers2
- HMW-VWF demonstrates increased hemostatic activity2
- HMW-VWF is associated with
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High specific activity2 |
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VWF:ristocetin cofactor (VWF:RCo) activity |
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Collagen-binding activity |
- High molecular weight von Willebrand factor is also associated with shortened bleeding time3
Like normal human plasma, Humate-P® contains a high percentage of high molecular weight von Willebrand factor (HMW-VWF) multimers2, and it is capable of correcting the hemostatic defect in patients with severe VWD.4
In fact, in an analysis of FVIII/VWF concentrates3,4, Humate-P® has been shown to have the highest HMW-VWF content. Click here to see an animated densitometric analysis comparing various VWF/FVIII concentrates and normal human plasma.
Important Safety Information
Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, Humate-P® is indicated in adult patients for treatment and prevention of bleeding in hemophilia A (classical hemophilia). Humate-P® is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate.
Humate-P® is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations, or to any of its components.
Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement, especially in the setting of known risk factors for thrombosis. Caution should be exercised and antithrombotic measures considered.
Humate-P® is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
The most common adverse reactions reported in patients receiving Humate-P® are allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, edema, shock, chills and fever, and hypervolemia. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding.
Please see full prescribing information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
The information provided herein is solely for use by physicians and healthcare professionals in the United States. The CSL Behring product listed may not have been approved in other countries and may not be available everywhere.
References
- Mannucci PM. Treatment of von Willebrand's disease. N Engl J Med. 2004;351:683-694.
- Metzner HJ, Hermentin P, Cuesta-Linker T, Langner S, Müller H-G, Friedbold J. Characterization of factor VIII/von Willebrand factor concentrates using a modified method of von Willebrand factor multimer analysis. Hemophilia. 1998;4(suppl 3):25-32.
- Berntorp E, Nilsson IM. Use of a high-purity factor VIII concentrate (Hemate P) in von Willebrand's disease. Vox Sang. 1989;56:212-217.
- Berntorp E, Nilsson IM. Biochemical and in vivo properties of commercial virus-inactivated factor VIII concentrates. Eur J Haematol. 1988;40:205-214.
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© CSL Behring 2010. The product information presented on this site is intended for US residents only.
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